1. Do not wait to submit a reportable event to the IRB until you have all the information about the event. Report the event promptly and follow-up with additional information as it becomes available.
  2. A UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) that is also a Serious Adverse Event must be reported ASAP, but no later than one (1) week from the time you become aware of the event.
  3. All other UPIRSOs must be reported ASAP, but no later than two (2) weeks from the time you become aware of the event.
  4. Protocol violations must be reported ASAP, but no later than one (1) week from the time you identify the issue.
  5. Other events that are reportable to the IRB include subject complaints and breach of confidentiality.

For more information, please review UNC SOP 19.0 and 23.0
https://research.unc.edu/files/2014/05/2014-04-24-OHRE-Standard-Operating-Procedures-FINAL-CLEAN.pdf

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